Li Yanjun, Liu Qing, Godefroy Samuel, Li Jingguang, Chen Yan
Research Unit of Food Safety, Chinese Academy of Medical Sciences (No. 2019RU014), NHC Key Laboratory of Food Safety Risk Assessment, China National Center for Food Safety Risk Assessment, Beijing 100021, China.
Food Risk Analysis and Regulatory Excellence Platform (PARERA), Institute of Nutrition and Functional Foods, Laval University, Quebec, QC G1V 0A6, Canada.
Foods. 2025 Jun 8;14(12):2025. doi: 10.3390/foods14122025.
Gluten has a central role in the pathogenesis of several gluten-related disorders, with coeliac disease being one of the most well-known. A rigorous gluten-free diet is recognized as the only safe and efficient coeliac disease therapy. This study intended to use the enzyme-linked immunosorbent assay (ELISA) R5 Méndez method to determine gluten contamination in labelled gluten-free food products marketed in China and to evaluate the performance of two ELISA platforms (the Neogen Veratox R5 and the Romer Labs AgraQuant G12) for analyzing gluten, using R5 Méndez as the reference. In 2024, 119 prepackaged products labelled as gluten-free were purchased from internet suppliers. The results showed that among the 119 products, 13.4% contained gluten exceeding 20 mg/kg, and 5.0% contained over 100 mg/kg, ranging from 333.1 to 2737.4 mg/kg. When the threshold for gluten-free products was 20 mg/kg, the two ELISA platforms yielded results comparable to R5 Méndez. However, when the threshold was 10 mg/kg and 5 mg/kg, the McNemar test showed significant differences between the proportions of positive results of the two ELISA platforms and R5 Méndez (-value < 0.05); using R5 Méndez as the reference, the two ELISA platforms showed 53.1% to 70.3% positive predictive values, suffering the drawback of high false-positive results. When using stricter gluten limits of ≤10 mg/kg and ≤5 mg/kg, different ELISA platforms may produce different results for the same food product. These findings highlight the need for China to accelerate the development of national standards for gluten-free foods, and for food regulatory agencies to impose requirements of production that lead to the prevention of gluten contamination, confirmed by the possible monitoring of such compliance through routine sampling and testing. Such measures will no doubt contribute to protecting and improving the health of patients with gluten-related disorders.
麸质在几种麸质相关疾病的发病机制中起着核心作用，乳糜泻就是其中最广为人知的一种。严格的无麸质饮食被认为是唯一安全有效的乳糜泻治疗方法。本研究旨在使用酶联免疫吸附测定（ELISA）R5门德斯方法来测定在中国市场上销售的标有无麸质的食品中的麸质污染情况，并以R5门德斯法为参考，评估两种ELISA平台（Neogen Veratox R5和Romer Labs AgraQuant G12）分析麸质的性能。2024年，从网络供应商处购买了119种标有无麸质的预包装产品。结果显示，在这119种产品中，13.4%含有超过20毫克/千克的麸质，5.0%含有超过100毫克/千克的麸质，含量范围为333.1至2737.4毫克/千克。当无麸质产品的阈值为20毫克/千克时，两种ELISA平台的结果与R5门德斯法相当。然而，当阈值为10毫克/千克和5毫克/千克时，麦克尼马尔检验显示两种ELISA平台的阳性结果比例与R5门德斯法之间存在显著差异（P值<0.05）；以R5门德斯法为参考，两种ELISA平台的阳性预测值为53.1%至70.3%，存在假阳性结果较高的缺点。当使用≤10毫克/千克和≤5毫克/千克更严格的麸质限量时，不同的ELISA平台对同一食品可能会产生不同的结果。这些发现凸显了中国加快制定无麸质食品国家标准的必要性，以及食品监管机构对生产提出要求以防止麸质污染的必要性，可通过常规抽样和检测对此类合规情况进行监测来加以确认。这些措施无疑将有助于保护和改善麸质相关疾病患者的健康。
